Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03193216
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2017-06-16
Brief Title:
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barretts Esophagus
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barretts Esophagus A Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy PPI in patients undergoing ablative therapy for dysplastic Barretts esophagus The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barretts over a shorter period of time
Detailed Description:
Barretts esophagus BE is a pre-cancerous condition in the esophagus that results from constant acid exposure and is a precursor to esophageal adenocarcinoma EAC Surprisingly EAC rates continue to rise despite efforts aimed at addressing BE Patients with dysplastic BE are at increased risk for developing EAC and in high grade dysplasia HGD this risk can be as high as 6 per year For these reasons these patients are candidates for ablation therapy either with cryotherapy endoscopic mucosal resection EMR andor radiofrequency ablation RFA In patients receiving ablative therapy 3-5 treatments are typically required before there is resolution of all Barretts epithelium while patients remain on twice daily proton pump therapy
A recent case study by the current authors demonstrated initial failed response of BE with HGD to RFA and subsequently cryotherapy Only after initiation of a liquid alginate solution Gaviscon Advance - UK formulation was there a subsequent rapid and complete response to therapy This case suggests that liquid alginate provided additional esophageal protection allowing mucosal healing and an overall enhanced response to treatment This finding is mechanistically plausible given existing evidence demonstrating the carcinogenic properties of bile acids and injurious activity of pepsin in non-acid refluxate and liquid alginates unique ability to control these components and inhibit acid reflux The investigators feel further investigation is warranted in studying the role of adjunct liquid alginate solution in patients undergoing treatment for BE
The ingredient of interest in is alginic acid alginate a polysaccharide found in the cell walls of brown algae Alginates are unique in their ability to form a protective layer above gastric contents upon exposure to gastric acid thus limiting exposure of esophageal epithelium to gastric acid bile acid pepsin and other parts of the gastric contents Concurrently the bicarbonate in alginate-based solutions forms carbon dioxide in the presence of gastric acid which converts the gel into foam which floats to the surface of the gastric contents Hence alginate solutions form rafts which provide a physical barrier to acid reflux as well as a pH-neutral substitute which refluxes preferentially over gastric acid
A recent case study by the current authors demonstrated initial failed response of BE with HGD to RFA and subsequently cryotherapy Only after initiation of a liquid alginate solution Gaviscon Advance - UK formulation was there a subsequent rapid and complete response to therapy This case suggests that liquid alginate provided additional esophageal protection allowing mucosal healing and an overall enhanced response to treatment This finding is mechanistically plausible given existing evidence demonstrating the carcinogenic properties of bile acids and injurious activity of pepsin in non-acid refluxate and liquid alginates unique ability to control these components and inhibit acid reflux The investigators feel further investigation is warranted in studying the role of adjunct liquid alginate solution in patients undergoing treatment for BE
The ingredient of interest in is alginic acid alginate a polysaccharide found in the cell walls of brown algae Alginates are unique in their ability to form a protective layer above gastric contents upon exposure to gastric acid thus limiting exposure of esophageal epithelium to gastric acid bile acid pepsin and other parts of the gastric contents Concurrently the bicarbonate in alginate-based solutions forms carbon dioxide in the presence of gastric acid which converts the gel into foam which floats to the surface of the gastric contents Hence alginate solutions form rafts which provide a physical barrier to acid reflux as well as a pH-neutral substitute which refluxes preferentially over gastric acid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None